Safety and efficacy of early oral oxycodone/acetaminophen and tramadol in Chinese gynecology patients undergoing laparoscopy operation / 中国临床药理学与治疗学

ABSTRACT

AIM: To evaluate the safety and efficacy of oral oxycodone /acetaminophen or tramadol in early postoperative patients undergoing laparoscopic gynecological operations. METHODS: 120 gynecologic patients receiving laparoscopy operation were enrolled in a randomized,double blind, placebo controlled, multi center clinical trial with early oral analgesics if the vasual analgesia scores (VAS) was scored higher than 3.0. All patients were randomly received a single dose of oral analgesic oxycodone/acetaminophen, tramadol or placebo, respectively. For rescue medication, PCA pump was provided in all three groups with a dose of 1 mg morphine and lockout of 5 minutes. The VAS scores, pain relief, PCA morphine consumption and side effects were evaluated at the following occasions of 0.25 , 0.5 , 0.75 , 1, 2, 4, 6, 8, 12 and 24 h throughout the study. RESULTS: The VAS scores and pain relief were significantly different in three groups at 0.75 , 1, 2, 4, 6, 8 and 12 h. The VAS scores and PCA morphine consumption was significantly lower in oxycodone/acetaminophen and tramadol groups than those in placebo group. Pain relief in oxycodone/acetaminophen and tramadol groups was better than those in placebo group. The incidence of side effects such as nausea and vomiting significantly increased in tramadol group at 24 h compared with those in the other two groups. CONCLUSION: Early oral administration of oxycodone /acetaminophen or tramadol can provide surgical patients with good and safe postoperative analgesia after laparoscopy gynecologic operation. The incidence of side effects in oxycodone /acetaminophen group is lower than that in tramadol group in this clinical trial.